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Safety

There are plenty of things new parents worry about, don’t let vaccination become one of them.
Infanrix hexa helps you give them confidence from the start, with less pain and fever for the baby
vs. DT2aP-HBV-IPV-Hib1

This has been confirmed in a meta-analysis of six head-to-head studies*1

*Primary schedule (2 or 3 doses received before 12 months of age)1

Results show that there are lower odds of developing the analysed local and systemic adverse reactions after vaccinations with Infanrix hexa vs. DT2aP-HBV-IPV-Hib1

The meta-analysis included head-to-head studies which compared adverse reactions following primary series vaccination with Infanrix hexa or DT2aP-HBV-IPV-Hib1

The analysis extracted data to estimate the incidence of 11 local and systemic adverse reactions, as well as any discontinuation, after primary vaccination with Infanrix hexa compared with DT2aP-HBV-IPV-Hib1

Adverse reactions included:1

Pain, redness and swelling at the injection site, any grade 3 event (local adverse reactions)

Fever, drowsiness, irritability, persistent crying, anorexia, vomiting, any grade 3 event (systemic adverse reactions)

Graph1

Odds Ratio <1: lower proportion of adverse events for Infanrix hexa vs. DT2aP-HBV-IPV-Hib

Orange data points indicate outcomes for which there was a statistically significant difference between Infanrix hexa and DT2aP-HBV-IPV-Hib
Blue data points indicate outcomes for which there was not a statistically significant difference between Infanrix hexa and DT2aP-HBV-IPV-Hib
The same results were first published in Mukherjee et al. 20211
The graph has been independently created by GSK from the original data

Safety of acellular vaccines vs. whole-cell vaccines

Currently, two types of pertussis vaccines are available:
whole-cell vaccines and acellular vaccines (such as Infanrix hexa)

Acellular vaccines can provide a more favourable reactogenicity profile vs. whole-cell vaccines2–4

2 to 3x fewer local reactions with 4 to 9x less risk of fever (≥38 °C) after primary series and booster dose with aP vaccines.**2,3 Higher reactogenicity may decrease vaccine uptake, while lower reactogenicity supports vaccine coverage which can lead to better disease control3

Graph1

The same results were first published in WHO 20144
The figure has been independently created by GSK from the original data
**This study used a GSK DTaP-IPV vaccine containing the same pertussis components as Infanrix hexa2,5

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Worldwide experience

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Immune persistence

A long immune persistence can offer reassurance; see how long immune persistence of Infanrix hexa has been followed-up

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Resources

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aP, acellular pertussis; CI, confidence interval; DTaP, acellular diphtheria-tetanus-pertussis; DT2aP, diphtheria, tetanus and acellular pertussis; DTwP, whole-cell diphtheria-tetanus-pertussis; HBV, hepatitis B virus; Hib, Haemophilus influenzae type b; IPV, inactivated polio virus; OR, odds ratio; WHO, World Health Organization; wP, whole-cell pertussis

Infanrix hexa safety information5

Contraindications:
Hypersensitivity to the active ingredients or to any of the excipients or residues. Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines, or if the child has experienced and encephalopathy of unknown aetiology, occurring within 7 days following vaccination with pertussis containing vaccine.

Warnings and precautions:
Administration should be postponed in subjects suffering from acute severe febrile illness. A protective immune response may not be elicited in all vaccines. Use with caution if any of the following has occurred in temporal relation to receipt of pertussis-containing vaccine within 48 hours:

  • Temperature of > 40.0°C.
  • Collapse or shock-like state.
  • Persistent, inconsolable crying lasting > 3 hours.
  • Convulsions with or without fever, occurring within 3 days of vaccination.

Pregnancy and lactation:
Infanrix hexa is not intended to be used in adults.

Adverse events:
Very Common – Appetite lost, pain, redness, local swelling at injection site (< 50 mm), fever > 38°C, fatigue.

References

  1. Mukherjee P et al. Exp Rev Vaccines 2021; 20:319–330.
  2. Dagan R et al. Pediatr Infect Dis J 1997; 16:1113–1121.
  3. Patterson J et al. Vaccine 2018; 36:6007–6016.
  4. World Health Organization (WHO). Information sheet: observed rate of vaccine reactions. Diphtheria, pertussis, tetanus vaccines. Available at: https://www.who.int/vaccine_safety/initiative/tools/DTP_vaccine_rates_information_sheet.pdf?ua=1 (Accessed April 2022).
  5. Infanrix hexa local prescribing information.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via Gulf-KSA.Product-Complaints@gsk.com

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PM-RCH-INH-WCNT-230001 | Date of preparation: February 2023